Compliance, Legalities, and Ethics in Audiology Today

This text-based course is a transcript of the recorded seminar, "Compliance, Legalities, and Ethics in Audiology Today," presented by Kim Cavitt, AuD. Please download supplemental course materials.

Welcome to Compliance, Legalities, and Ethics in Audiology Today. I am Kim Cavitt and I will be talking today about how these three things interact in the work we do as audiologists. First, I want to start with a reality check so you can see what I will be discussing today and understand how important this information is to the way you conduct your day-to-day practice.

There are eight important concepts that comprise what I am referring to as the reality check. Let's go through them one by one.

1. Ignorance is not a defense. For example, if you are audited by Medicare or you are called to utilization review by a third-party payer and your response is "I didn't know", this does not mean that you will not have to pay back claims that were associated with that audit. Not knowing is not enough to get you free and clear of any situation you are in, especially if it comes to licensure or audit.
    
2. Rules, regulations, guidance and laws do not have to be interpreted or manipulated to fit your practice. Rather, you need to modify or adjust your practice operations to the rules, regulations, guidance or laws that exist. It is important that you become aware and educate yourselves on the rules, regulations, laws and statutes that apply to you and your practice, both at the state and federal levels. When you find that the way you practice day-to-day does not agree with that regulation, you need to change what you are doing to make sure that it is fitting within the regulation.
    
3. There is no excuse for not following the rules. All of our national associations in audiology, such as American Academy of Audiology (AAA), American Speech-Language Hearing Association (ASHA), and the Academy of Doctors of Audiology (ADA), provide guidance to their members on the rules and regulations of Medicare, as well as links to rules and regulations at your state level. All the guidance you need to follow the rules is right at your fingertips from your national associations.
    
4. Make informed decisions, not decisions based on fear or greed. Rather, make decisions based on what is the right thing to do, and what is the right way forward.
    
5. Vendors are not always your friend and are not always looking out for you. Vendors are responsible to their employer, their company, and their shareholders. They are not responsible for you. You are responsible for you and your practice. When a vendor gives you a contract to sign, they have had it vetted by their council to protect them, not to protect you. In an audit, you are the one who received the payment. You are the one who is contracted with the third-party entity, not them. Therefore, you are the one who would be paying the money back or hiring counsel to defend your action. The vendor will say the contract was something they signed and it was your responsibility to have your council review it for its appropriateness to your legal situation. Before you sign any agreement with a vendor, you should have it vetted by your own council to make sure that there are protections in that agreement for you as the provider.
    
6. Don't worry about everyone else. You need to do what is right. Just because someone else is breaking the rules, not following regulations or has agreements where they are ethical compromises, does not mean that this practice is right. It just means they have not been caught. You need to educate yourself on what is the right thing to do, both ethically and legally. You also have the right to turn the other person in for whatever rules they are breaking once you know that what they are doing is indeed incorrect.
    
7. Utilize the skills of experts when you do not know for sure what is right or correct.
    
8. Enforcement is on the rise! As a consultant, I saw more audits in 2011 than I had seen in my previous 10 years of consulting combined. In a down economy, regulation will be enforced. Utilization reviews or audits of providers based upon their agreements are supposed to be conducted, per Medicare and Medicaid. Now audits are being conducted and people are being held to the statute in its true form. It is important that you realize just because audiology is a small profession does not mean we are immune to audits. I have seen many colleagues and clients audited. The Office of the Inspector General, which polices Medicare, has a 10 most wanted list. This can be found at https://oig.hhs.gov/. On this list is not just 10 physicians. Sometimes it is physical therapists, speech language pathologists, otolaryngologists, or durable medical providers. It depends on how big the infraction is or how pervasive. Anyone can be caught in an audit. Even if the audit is small, they can extrapolate the audit by 100 or by 10. The numbers you may owe can be in the $20,000, $30,000, or $40,000 range, which would be a hard hit for many audiology practices. Even if they found you to be a good service provider, you may still have to pay back for small infractions of regulation.
    

• Conflicts of interest. Conflicts of interest can either be perceived by the patient or real. Conflicts of interest are you getting something personally or professionally because you are providing a specific product or item to a patient. Conflicts of interest are also quid pro quo (You do something for me and I'll do something for you). Conflicts of interest can be actions perceived by you as not a problem, but your patient would perceive it as a conflict of interest. You need to evaluate not only how it is perceived, but also the legality of the potential conflict. Another issue would be hearing aid commission. If your patient knew you received commission for dispensing their device, how would they feel? Commission is a perfect example for a potential conflict of interest. As an employee, if I were in a situation where I was being paid via commission and I was a Medicare or Medicaid provider, I would want my council to review my reimbursement or compensation structure with my employer to make sure that this is not a conflict of interest and has no legal issues.
   
• Ownership interest in companies whose products you dispense. For example, you have ownership in a company whose product you use, whether ownership is within a member of the buying group or ownership is direct with the company itself, and you are dispensing that product to a patient, are you disclosing that ownership to your patients? Do they understand those implications? These are arrangements that you should have legally vetted with council to help you know how to best handle your interactions with your patients and any payers.
   
• Disclosure of commercial interests to patients or disclosure of consulting relationships with patients. If you are being paid by a vendor for research, to participate in a beta project, if you are getting product for free that you can then sell as part of that beta project and then you are selling that to a patient, are you disclosing this information to the patient?
   
• Acceptance of gifts of any value from manufacturers. The Center for Medicare and Medicaid Services (CMS) that governs Medicare says gifts should be less $10 per gift or less than $50 per year. Gifts such as pens and paper may be trivial, but others such as a computer, iPad, or free products (if you bought 9 products, did you get one free?) are not. Before you sign those agreements or accept those gifts, you owe it to yourself to have it reviewed by council. If a patient, competitor, disgruntled employee, or disgruntled referral source who wonders where that equipment is coming from turns you in, these arrangements would be investigated and you want to make sure that they pass the legal sniff test.
   
• Disclosure of remuneration or payment in like or kind, whether product or money, for performing research.
   
• Incentive trips rewarded for conducting business. For example, you are a manufacturer's biggest account so they take you on a trip. AAA guidelines are very clear that the training or event should be educational in nature. Ethical Guideline #3 states "Members should not attend or participate in educational events where the member or the participants are rewarded for conducting business with a specific manufacturer and/or where a quid pro quo relationship exists between the attendee and the manufacturer. Such rewards to be avoided may include, but are not limited to, discounts on device purchases for attending an event, entertainment, travel to exotic resort facilities for educational events, and prizes for attendance" (AAA, 2011). According to these guidelines, you should never accept anything that is beyond reasonable travel for expenses, meals, and lodging. Members are encouraged to pay for their own educational expenses. It is important to understand that just the perception of an unethical situation can be problematic. Even if gift or trip does not influence your decisions, what would your patient think?
   
• Business development funds. Many of these funds can be cashed out for cash. It is important that you have those agreements in writing. Some of these arrangements are completely legal, but you need to make sure that your arrangement is. An alternative to the business development fund could be getting a better per unit discount.
   
• Lease arrangements. If you have a lease with a vendor or entity, is it at fair market value? Is the interest at a fair market rate? Before you sign, have this reviewed.
   
• Cash rebates. Is a vendor giving you cash at the end of the month or quarter based upon your sales? This can be problematic because a rebate would be considered a violation of Anti-Kickback.
   
• Sales quotas with a manufacturer in order to receive a particular incentive. This has been shown to have a great influence or conflict of interest in the way we determine what is in the best interest of the patient.

I am giving this presentation to provide you with the tools to investigate these guidelines. I am not judging any arrangements. Many arrangements are completely legal and appropriate. However, after you have read all the guidance I have given, if you are not sure they are completely legal and appropriate, it is important that you have council review these arrangements.

When Ethics Violations Turn Into Legal Problems

When ethics become "shady" or "gray", you could be violating law.

Anti-Kickback legislation. The first law we will discuss is the federal Anti-Kickback legislation. Anti-Kickback legislation is mentioned in many state licensure laws. If you violate anti-kickback laws, you are violating the licensure law. This language exists in Medicare and Medicaid agreements, and can also exist in agreements with private third-party payers. There is a criminal penalty and you could go to prison for gross infractions of anti-kickback.

In 2009, the SBI came with OIG to Chicago and some physical therapists were walked out in handcuffs because of their violations with anti-kickback. You need to be aware of this rule and how it can be interpreted very broadly. The status says it is a felony to knowingly and willfully solicit or receive any remuneration, directly or indirectly, overtly or covertly, in cash or in kind, in return for purchasing, leasing, or ordering (or recommending the purchase, lease, or ordering) of any item or service reimbursable in whole or in part under a federal health care program (except for the Federal Employees Health Benefits Program). Direct remuneration can come from a vendor and indirect remuneration can come for a middle man such as a buying group. In the statement "in cash or in kind", kind can mean travel, equipment, or product. This does not include the Federal Employee Health Benefits plan administered by Blue Cross Blue Shield or Anthem here in this country, but it does apply to Medicare. Some people would say Medicare does not pay for hearing aids so this does not apply to audiologists, but remember that Medicare pays for Baja, and Medicare pays for cochlear implants. Those types of relationships could be governed by anti-kickback by Medicare. Many of us dispense hearing aids through a Medicaid program. Anti-Kickback applies to any hearing aid purchase. Tri-Care which is the active duty military program would also apply or any devices or products you are providing to a veteran through VA outsourcing. Anti-Kickback was created because they believe that getting kickbacks or getting some sort of quid pro quo creates an incentive to over-utilize particular goods and services, impinge upon the patient care process, and create an unfair competitive environment to those who refuse to provide remuneration. Particular is in the important word in the sentence. You may over-utilize a particular vendor's product over another product that may be better for the patient because you are getting something back. It is not fair to the people who follow the rules and do not receive remuneration. If you have decided that it would not be appropriate to have a business development fund, those who are still doing it are getting an unfair advantage over you. Is that fair that you are following the rules and they are not? This is where Anti-Kickback comes in. Here are some examples in the field of audiology. These were actually posed to me in the course of my work.

• An audiologist furnishes hearing tests to a physician's patients in their office at less than fair market value in exchange for hearing aid referrals where some of these referrals may be for instruments covered under a Federal health program. The doctor states if you do my hearing tests for free or $10, $20, or $30 an hour, which would be low in many cases, I will send all my hearing aid patients to your practice. This would be a violation of anti-kickback if any of those instruments that he refers to you are paid for by a third-party payer such as Medicaid or Tri-Care.
   
• An audiologist accepts gifts that exceed $10 per item or $50 annually from a hearing aid or implant manufacturer in return for fitting their hearing aids where some of these fittings may be for instruments covered under a Federal health program such as Medicaid or Tri-Care.

There are ways around this, but you need to work with the manufacturer in the contract and then you need to work with your attorney. If you still feel like it is ethically appropriate for you to participate in some of these arrangements, and none of your Medicaid or Tri-Care hearing aids would funnel through this account, but would funnel through another account.There are alternatives, but they have to be explored with the vendor and council.

Other things to avoid in the Anti-Kickback legislature as it relates to Audiology:

• Free hearing tests. AAA, ASHA, and ADA worked together to create a Medicare FAQ document which is posted on all three websites of the national associations. All information is the same on each website so that we as a professional community could speak in one voice about what the answers to these questions are. Providing free hearing tests when you are a Medicare provider appears to be a clear violation of Medicare rules and regulations. Medicare prohibits offering free services such as hearing testing as an inducement to generate other services such as diagnostic audiologic services or hearing aid services. Medicaid feels the same way. Many third-party contracts state this as well. You cannot charge a patient with private insurance for an item or service that you are going to give away to others such as Medicare beneficiaries for free. Pure tone air conduction testing is not a screening. It is a pure tone air conduction threshold testing which is part of code 92557. You cannot give that away for free. You cannot fit or demo a hearing aid from a test/service that was provided free of charge because they are covered services. You can do screenings, pass/fail, 20 or 25, or cross of frequencies for free, or charge the patient privately as Medicare does not pay for screenings. Some private insurance companies may pay for these screenings and you may be violating your agreement with them if you give it away for free. You cannot give free services if you are enrolled in Medicare. Dispensers can do this, because they are not enrolled in Medicare. If a dispenser gives screenings away for free to a Medicare beneficiary, but they charged Medicaid for it because they are allowed in that program, that would be a violation as well. It is important to know the rules for the particular programs in which you are enrolled. For Medicaid, you need to know the rules for Medicaid. For Medicare, they do not allow free. If it is a private insurance, read the contract to see if they want their members treated the same as everyone else.
   
• Use of referral pads. There is precedence in audiology about the use of referral pads being audited and losing those audits. Referral pads that contain identifying information of a specific clinic are marketing pieces. They are created to solicit orders and business. As a result, they have been deemed a solicitation which violates Anti-Kickback. If you insist on using a referral pad, it needs to have no identifying information of your practice on it. It needs to be something a physician can use no matter where they want to refer the patient. On a side note, if you go and do a health fair, you should provide the attendees of the health fair with a list of numerous providers within the community. Your name can be first on the list, but you need to make sure you are not soliciting business by adding other viable alternatives.
   
• Write-offs of co-pays and deductibles. Medicare is very clear that you are not allowed to uniformly write-off the Medicare 20% co-insurance or the deductible amount in order to bring in more business. That is the financial responsibility of the beneficiary and they are obligated to pay. If you are billing them and they are not paying you, you need to at least bill them for three months before you write it off to bad debt. You need to have this fully documented that the patient was billed and never paid. You also need to make sure this is not a pattern. If there is a pattern of non-collection and write-offs, they will investigate you from a kickback scenario.
   
• Reminder mailings for annual type hearing tests. If you send an annual hearing test reminder to a patient you bill privately, this is fine as the patient would be responsible for the cost of the test. If you want to bill Medicare for a hearing test that you reminded the patient of, that reminder card could be deemed a solicitation. Instead remind your patients of already scheduled appointments with a note stating the test may or may not be covered depending upon medical necessity and they may be financially responsible. Then call the patient and remind them of their appointment.

All of these actions above could be construed as solicitation of Medicare/Medicaid covered services.

The details of the Anti-Kickback statute are "Section 1128B(b) of the Social Security Act (42 U.S.C. 1320a-7b(b)), previously codified at sections 1877 and 1909 of the Act, provides criminal penalties for individuals or entities that knowingly and willfully offer, pay, solicit or receive remuneration in order to induce business reimbursed under the Medicare or State health care programs. The offense is classified as a felony, and is punishable by fines of up to $25,000 and imprisonment for up to 5 years." The provision is extremely broad. The types of remuneration covered specifically include kickbacks, bribes, and rebates made directly or indirectly, overtly or covertly, or in cash or in kind. In addition, prohibited conduct includes not only remuneration intended to induce referrals of patients, but remuneration also intended to induce the purchasing, leasing, ordering, or arranging for any good, facility, service, or item paid for by Medicare or State health care programs.

Safe harbors. CMS realized that there may be some scenarios that are innocent, and anti-kickback is so broad you could criminalize some innocent scenarios, so they created Safe Harbors. The Office of the Inspector General created exceptions or "safe harbors" to anti-kickback to avoid criminalizing innocent conduct or business arrangements. The link for the list of Safe Harbors is oig.hhs.gov/compliance/provider-compliance-training/files/ListofAKSSafeHarbors508.pdf. They include "arm's length" (which means the parties do not have a close relationship or, in other words, are not related) agreements for the rental or lease of office space or equipment, discounts, waivers of co-payments, and remuneration given to employees. For example, you own a private practice and your spouse is an otolaryngologist. He will order tests and you will refer back and forth. That arrangement should be clearly vetted by council to make sure that it is protected by the Safe Harbors because you are related. It is important that these relationships are set up clearly so there is no sense of impropriety. All rental agreements should be in writing especially with referral sources or with someone you are leasing equipment or space from. You must have at least a one-year rental agreement. You should not have short-term scenarios where you are paying way more than fair market value. All your costs must be consistent with fair market value.

Stark Laws. Stark Laws carry civil penalties, not criminal and they prohibit physician self-referral. The links are:

• oig.hhs.gov/compliance/provider-compliance-training/files/StarkandAKSChartHandout508.pdf
   
• oig.hhs.gov/compliance/provider-compliance-training/files/PhysicianSelfReferralExceptionHandout508r2.pdf

Just for your information, there is a Stark exception, or a physician self-referral exception, that ENTs can profit from ancillary health services provided in their own office. This is why there is very limited application in Audiology, because we are not an ordering entity so we cannot refer. Since we cannot refer, Stark laws have very little implication to us.

False Claims Act. The next topic, that most concerns me in Audiology and I see many Audiologists inadvertently do, is false claims. This is mentioned in every state licensure that I have read and in every private contract I have read, as well as Medicare and Medicaid. The False Claims Act carries a criminal penalty. Information on the False Claims Act can be found at www.falseclaimsact.com/common_frauds_healthcare.php. The bottom line is you do not submit fraudulent claims to anyone, no matter who the payer is. You never want to submit a false claim because all payers have this language in their rules. Examples would be:

• Claims for services not performed. One example would be you billed for rotational chair testing which is code 92546 and you do not have a rotational booth. Instead you were actually doing a head shake. There was no code for a head shake so you billed for rotational testing. You just billed an entity for a service you did not perform. Another example is billing an entity for a comprehensive hearing test with air, bone, speech, SRT, and Discrim, but you did not do the bone test. You just billed for bone and it was a service you did not perform. Coding and documentation should always reflect the services you actually provide. Do not be creative in your coding. If your service or test does not have a code, use the unlisted code. Another example is billing VEMPS using the ABR code. The ABR code is auditory evoked potential. When you did VEMPS, you did a visual evoked potential, not an auditory evoked potential. As a result if you bill, an ABR for doing VEMPS, you billed for services you did not render.
   
• Billing under someone else's provider number. This happens all the time. Here are two examples. You just hired an audiologist and this audiologist has yet to be credentialed or licensed, but you are paying them while they get their paperwork done. This employee performs a hearing test on a Medicare beneficiary. They are not a student anymore, but they do not have a Medicare pin yet and they are not credentialed. That claim would be denied. So instead of charging the patient privately for that test which you legitimately could do as long they were licensed, you chose to bill Medicare under someone else's provider number. This is considered a false claim. Another example would be if you go on vacation and someone fills in for you, but because they are not credentialed to your practice, you are going to bill everything under your provider number. This is also a false claim. I have seen many instances at OIG of other professionals getting caught from this actual scenario. No service can be billed out under your provider number that you did not personally provide yourself. If you are supervising or precepting a student with 100% personal supervision, you could bill that under your provider number. Personal supervision means you never leave the room. You write the report. You document everything.
   
• Unbundling or breaking a code into the sum of its parts to increase reimbursement. The best example is the unbundling of the vestibular code family. Vestibular codes, optokinetics, oscillating, tracking, gaze and positionals were combined into a singular code, 92540. If you break it into pieces in an attempt to increase reimbursement, but do not document why you left out some of these other procedures, you could be unbundling. This could be flagged and considered a false claim. If you are going to only perform 2 or 3 of the four-bundle, you need to bill it out with the -59 modifier. This way they know this is distinct procedural services. Also your documentation should support why you did not do all four pieces or why it was medically necessary to leave out a part of this testing.
   
• Upcoding. An example would be billing for a comprehensive hearing test when all you did was an air conduction test or billing for VRA and 92557 for the same patient on the same date of service. Another example would be billing for a comprehensive hearing test and not adding a modifier when you only tested one ear. If you did not do bone, your documentation should show that you did not do bone and you need to bill air, SRT and discrim, and not bill the comprehensive code. If you do not perform discrim, there is no way to bill for discrim in isolation. This would mean that you would have to add a reduced modifier which is -52. Your coding should always represent what you actually performed or it could be considered upcoding.
   
• Billing for services known to not be covered and not adding the appropriate modifier. An example would be billing hearing aids or AR to Medicare and you do not add the modifier GY which shows you know the item or service is statutorily excluded. Without doing this, you have billed hearing aids to Medicare. This is problematic and could be a false claim.
   
• Submitting claims for services which were not medically necessary. The shining example in Audiology is the annual hearing test or billing for evaluation of AR status when this is a straight hearing aid patient. Another example would be testing solely for the purpose of a hearing aid such as the patient lost their hearing aid and they need a hearing test to get them a new one. Please know that the presence of a physician order does not guarantee medical necessity. You must have documentation in your records to show a change in history or symptom or monitoring of a condition or treatment. A change in hearing with an order could be medically necessary, but the fact that the patient wants a hearing aid or one year has passed is not. Tympanometry is a good example. You do not perform tympanometry on every patient. It is only medically necessary when the presenting condition indicates something that tympanometry can diagnose. I am seeing audits of people getting caught for not being able to document medical necessity.

FDA Requirements

The FDA is very clear about what their requirements are to dispense a hearing aid. We will be learning over the next several months in this series whether or not something is a hearing aid versus a PSAP. Today I am going to discuss the FDA guidelines in and of themselves. Many state laws reference the FDA guidelines or the FDA referral red flags of ear disease. There are eight red flags listed below.

• Active drainage within previous 90 days. Has the patient had a draining ear? If so, you need to refer them to someone who specifically specializes in the ear before you would move on to any treatment or amplification.
   
• History of sudden or rapidly progressive hearing loss.
   
• Unilateral hearing loss of greater than 15 dB at consecutive frequencies.
   
• Conductive hearing loss or air-bone gap. Conductive losses of greater than 15 dB at consecutive frequencies.
   
• Impacted cerumen (you cannot visualize the ear drum) or foreign body in the ear canal. If allowed by your state licensure law and you have the appropriate tools to remove impacted cerumen, you could do this yourself. Otherwise this patient should be referred to another entity.
   
• Pain or discomfort.
   
• Visibly congenital or traumatic deformity of the ear. This could include otic trauma, a busted ear drum, or others that you can see.
   
• Acute or chronic dizziness. Tinnitus is not listed here, but I would add it for consideration. If your patient is dizzy after you evaluate them, you should refer them, per the FDA guidelines, for an otologic evaluation.

The FDA also addresses devices here. This is good to review as many state dispensing laws reference the FDA guidelines. One thing that is required by the FDA is the patient needs to get a user brochure. You need to make sure that the booklet that the manufacturer sends with the hearing aid is sent home with the patient. If a patient is under the age of 18, they need to have a medical clearance, even if this is a subsequent hearing aid. A medical clearance is needed for every hearing aid purchase. This is the same with referrals. If a patient had a change, you need to refer the patient for medical evaluation. You need to get a medical clearance every time you fit the hearing aid. If the patient is over 18 years of age, they may sign a medical waiver to waive the need to see a physician. This should be kept in the patient's medical record and should be in the FDA language or the language put forth by your state licensure law.
 

In October of 2008, CMS created a document called the Update to Audiology Policies . I would like all of you to please read this information. It outlines our role in the Medicare system. I also would like for you to read the Revisions and Re-Issuance of Audiology Policies which went into effect in September of 2010. It clarified questions that emerged from the original update to audiology policies from 2008. These two documents spell out our role in the Medicare system. As a Medicare provider, you need to be aware of the requirements of that role.

The Update to Audiology Policies document addresses the following scenarios and I will discuss each individually.

"Incident to" Billing

The first item discussed is "Incident to" billing. "Incident to" billing is what audiologists who worked in ENT settings did for a long time. This means you provided the test, but the test was billed out under your rendering or attending physician. Medicare prohibits this now. All hearing testing performed by an audiologist must be billed under the national provider identifier (NPI) of the audiologist who performed the service. This cannot be billed under the NPI of the physician who ordered the service or the physician who is attending or owns the practice. A diagnostic hearing test, 92557, tympanometry, and VRA all require the skills of an audiologist. In requiring the skills of an audiologist, they must be billed out under the NPI of the audiologist who actually performed the service. This is for Medicare. Private insurances can make their rules.

Required Physician Orders

CMS discussed the required physician order. We, as audiologists, do not have direct access to Medicare care and to Medicare beneficiaries. As a result, we need an order from a physician in order for that test to be covered by Medicare. Because it is within our scope of practice to provide the test, we can provide the test without an order, but the patient is then financially responsible for the cost of the test. Orders are best received by two means which are hand-delivered mail or email. These can also be faxed. The order does not have to be signed and should simply state the patient's name, date, and audiologic evaluation needed. They can add diagnoses if they so choose, but it is not required. Telephone ordered should be avoided. The major reason is a telephone order must be documented in the medical record of the receiver of the telephone order and the entity who ordered the testing. As someone who has worked with physicians for many years, I would not trust an ordering physician to pull charts and document in the record, or open the EMR and document that they ordered a test. I encourage audiologists to require the orders be done in writing via hand or email. The order must be in place for each incident of care prior to the service being rendered.

Treatment Services Exclusion

The Audiology Policies addressed the fact that audiologists are statutorily excluded from receiving payment from Medicare for treatment that they provide. This does not mean that you cannot provide treatment. You can provide any treatment allowed within the scope of practice of your state licensure. It does mean that Medicare will not pay for it and the patient will be financially responsible. Some examples of this treatment are oral rehabilitation, canalith repositioning or vestibular rehabilitation, tinnitus management or rehabilitation, cerumen removal, all treatments. These are examples of what the Medicare beneficiary would need to reimburse you for privately.

Computerized Audiometry

Medicare does not reimburse for computerized audiometry or hearing tests that are not performed by real people. They do not reimburse for anything that is completely computerized or automatic in nature. Otograms are non-covered procedures by the Medicare system, but they could be paid for privately by the patient.

Roles of Technicians and Supervision

CMS discussed the role of technicians and their supervision requirements. Technicians cannot perform testing incident to an audiologist. This means the technician cannot perform the test and bill it out under the audiologist. Technicians can only be supervised and provide services incident to a physician. In Audiology, there are only three services a technician can provide. They are OAEs, ABR, and the vestibular evaluation family of codes. A tech cannot perform a hearing test and have that test legitimately covered. The technician can perform these three services under the supervision of the physician who is actively involved in the patient's care and available within the office suite, and have it be billed out under the NPI of the attending physician.

Role of Students and Supervision

CMS also discussed the role of students, including but not limited to, the final year extern and their supervision requirements. However there is information that we have yet to receive from CMS based upon a presentation they made at AAA three weeks ago. I will give you information based upon the knowledge that I have today. I strongly encourage you, if you are a preceptor, that you keep abreast and read any guidance provided by your national associations as we get more clarifications of this issue. I firmly believe that what I am telling you today is correct, but it should be clarified based upon something that was said in a presentation. Our students are not licensed entities. As such, they cannot perform testing on Medicare beneficiaries and have the testing covered unless they are being personally supervised. The audiologist or physician should be in the room 100% of the time, making the clinical decisions, and documenting the medical record. You cannot run parallel schedules with a fourth-year or with a student. If you are not in the room, making the clinical decisions and not documenting the medical record, that test would become the financial responsibility of the patient and would not be covered by the Medicare system.

Medical Necessity

Medicare also discusses medical necessity in the Audiology Policies. In the document links I added, you see where they discuss this. They also discuss this in chapter 15 of the Medicare Provider manual in section 80.3. Medicare covers or reimburses each individual test that has been ordered by a physician if it is necessary to diagnose or treat a medical or surgical condition, monitor treatment, or management of a medical or surgical condition. If a patient had a condition where you are monitoring ototoxicity, monitoring Meniere's, or monitoring gentamicin injections, this would be medically necessary. However if you have an office protocol that you do tympanometry on every patient regardless of their case history or you do OAEs on every patient, this is problematic. If you were audited, you would have to defend the medical necessity of every one of those tympanograms or OAEs individually for that specific patient. Giving the reason of best practice or office protocol will not work. You must document from case history and the results as they are happening why you did what you did. Medicare does not pay for routine, for annual, or for tests done under office protocol. You need to look at each patient as an individual entity and document your results such as "Tympanometry was performed due to the patient's report of aural fullness." Documentation is not only about covering your behind, but it is about good patient care. The ordering physician will appreciate the level of information that you have provided them.

Billing of Technical and Professional Components

The billing of the technical and professional components was discussed as well. The Update allowed us, as audiologists, to not only perform the tests, but to interpret the tests. This had not existed prior to this. We can bill the global code, not just the technical component. However there could be a scenario where you perform the test, but the ordering physician is interpreting it. If that is your clinical arrangement, you could only bill the code with a TC modifier and the physician would bill the code with the PC or the -26 modifier.

Documentation

Documentation is another place where audiologists do not realize their responsibilities. You are responsible to document medical necessity, not the physician. An order does not guarantee medical necessity. You are the billing party. You should do a comprehensive case history and then make clinical decisions based upon that case history over what tests are required for that specific patient. You should document in the record the case history, why you did what did, the results of what you did, and your plan of care. This follows the Subjective, Objective, Assessment, and Plan format of documentation. Many times I have seen where the plan of care was not documented. We need to be giving a comprehensive picture of the patient. Sometimes patients will tell us as their audiologist something they did not share with their physician. This should be documented in the chart and in the report sent to the ordering physician, even if you are they employee. Even though you work for an ENT, your documentation requirement is not waived.

92700 Code

The 92700 code is an unlisted otorhinological item or service. This is the code you should use to bill an item or service that does not have a code. Some examples are VEMPs, head shake, saccades, and use of goggles. These do not have specific codes, but it does not mean that you cannot submit that to a payer as long as it is allowed within your scope of practice. You would use 92700 and put a description of what you did. Then you would need to send hard copy documentation to show to describe the procedure or service, its clinical utility for this particular patient, the equipment required to perform it, the time required to perform it, the skills of the tester, and the costs you have allocated to that procedure based upon the other criteria. You should also send with that a copy of the patient's report. Anytime you use 92700 I would recommend an advance beneficiary notice as a required notification and I would have the patient pay privately for the procedure on the date of service and then reimburse them if Medicare does pay. These are individually reviewed codes and Medicare pays very sporadically. This will also allow patient's with an ABN to opt out of receiving the procedure if they are potentially going to be held financially responsible.

"Opting Out"

In the Update to Audiology Policies, CMS clarifies that we as audiologists cannot "opt out" of Medicare. Audiologists cannot enter into private contracts with Medicare beneficiaries. Medicare beneficiaries have the right to access their benefits. As a result, Medicare beneficiaries have the right to mandatory claim submission. When they come in to your office, you cannot charge them for a hearing test that was medically necessary, meaning you had an order and medical necessity was met. You cannot charge the Medicare beneficiary for that, you have to bill Medicare for reimbursement. In order to bill that to Medicare, you have to be enrolled in Medicare. There is no mechanism in which an audiologist is just not enrolled in Medicare and is charging patients privately for all their testing. That would violate Medicare's mandatory claim submission guidelines. You must bill Medicare and collect payment from Medicare for testing that meets medical necessity where you have obtained an order. There are many audiologists who are not enrolled in Medicare and are having patient's pay them for testing. If you want to give testing away, give it away to everyone because I will tell you that the private insurers will say you cannot charge me (BC/BS) for a test that you are giving away to Medicare beneficiaries for free. You need to be aware of what you contractually obligated yourself too. You must read your third-party contracts and know these are legally binding documents. This will legally impact some of your practice decisions and pricing decisions you make. You need to make sure you read these documents and make sure that you are not in violation of the Medicare statute.

Comprehensive Outpatient Rehabilitation Facilities

Also if you work in a comprehensive outpatient rehab facility (CORF), Medicare does not cover testing performed in your facility. This means any testing done would be the financial responsibility of the patient.

I would like to reiterate that you should read the guidance from Medicare. It is clearly written. It was authored by an audiologist. It is very succinct in how it describes our role with the system. If you have questions about that, please feel free to contact me privately or contact your council or employer, to make sure what you are doing it correct. It is important not to worry about yesterday, but about tomorrow in that you do not want to continue doing the wrong thing when you are not sure. You need to read your state licensure laws and the guidance from the Office of the Inspector General about anti-kickback and false claims. These are very easy-to-read short documents. You must understand what you have obligated yourself to either with your relationship with national associations, relationships with a vendor, relationships with a third-party payer, or your relationship to licensure and the government. It is important to know both your rights and your obligations.
 

HIPAA, the Health Insurance Portability and Accountability Act of 1996, is managed by the Office of Civil Rights and the Office of Inspector General through Health and Human Services at the federal government. This information can be found here. HIPAA carries both civil and criminal penalties. We will address each of these individually. HIPAA keeps going into effect. There were aspects of HIPAA that went into effect in 2011. There were HITECH and security aspects of HIPAA. HIPAA is ever-changing. Just because the vast majority of HIPAA went into effect October 1, 2003, does not mean that we have to forget about it. It means we have to keep educating ourselves when HIPAA changes and continue to comply with HIPAA guidelines.

Standard Transaction and Code Sets

HIPAA first was created for standard transaction and code sets. That meant that payers, Medicare or third-party payers, need to use the same coding system. They could not make up their own codes. The vast majority of payers in this country use Current Procedural Terminology (CPT) coding or the 92 codes, in our case, to represent the testing or procedures we provide, ICD-9 to represent diagnoses and symptoms (soon to be ICD-10 in 2014), and HCPCS codes to represent, in our case, hearing aid related or implantable device services and product. These are the coding systems you are supposed to use across all claims. MediCal has an exception where they can create their own codes. Most of the rest of the Medicaid systems in this country have become HIPAA-compliant. They no longer have the HIPAA exclusion. MediCal in California still has this exclusion and you have to use a special code set for some hearing aid related items or services. Worker's Comp also does not have to abide by HIPAA. They are outside the HIPAA guidance. They can have their own code sets. All private insurers, Medicare, and the vast majority of Medicaid have to follow standard transaction and code set rules.

Privacy

The next part of HIPAA that went into effect in 2003 was privacy. Patients have 18 pieces of protected health information such as name, address, phone number, date of birth, medical record, personal photo, credit card numbers, your social security number, etc. These are all protected when they are unique to you. Privacy in HIPAA set forth protections that needed to be in place to protect someone's protected health information or PHI. From a practical standpoint, every practice needs a privacy officer and that privacy officer needs to be the person patients can file complaints to if they feel like their privacy has been breached in any way by your practice. You need to have a notice of privacy practices. You need to have a full privacy policy that people can access and then if you want to have a miniature one, this is acceptable. The full privacy policy should outline the patient's rights and responsibilities, and provider rights and responsibilities within the HIPAA Act. This should contain the name of your privacy officer and the contact information for them, as well as the contact information of the Office of Civil Rights if they wish to file a complaint to the federal government. This is a complaint-driven process. It needs to be dated for its effective date. The patient will only need to sign the privacy acknowledgment once, unless you change your privacy policy. I recommend the privacy officer be someone in your practice who will not change such as the owner or manager of the practice. If you change the privacy policy officer, you must change your HIPAA document. Patients must receive your new HIPAA document and must sign a new acknowledgment. It is important that your privacy documents be dated. Privacy also stipulates that you must make a good faith effort in obtaining a patient's signature and date of receipt and recognition of your privacy policy. I am a big advocate of having this document free standing for when you do make changes, but in an effort to cut down on paper and forms, you can add this acknowledgment to your initial patient registration form.

Marketing. You also need to have an acknowledgment of marketing. Audiologists make this mistake all the time. Many times it is because they have listened to the vendor or consultant they hired who knows nothing about HIPAA. You cannot market your database without their permission. Marketing is a very loose term. I would tell you to think about what your goal is. If you are just trying to educate your patients that you have had a change in location or a change in staff, this would not need a release. However if you are telling them about a promotion or new hearing aid items, you are marketing to them. If you feel you are marketing to your patients, they are going to perceive it as marketing also. You must have their permission to send marketing materials to them. This is required under HIPAA. Within your HIPAA documents, you should have an acknowledgment for the patient that you may send them marketing materials.

Business associate contracts. A business associate contract is an agreement between you and any entity, which you send protected health information to and any protected health information they have access to or that you sent to them, where the protected health information will be protected. Some examples in Audiology of people who you should have business associate contracts with are hearing aid manufacturers, ear mold manufacturers, cochlear implant manufacturers, your accountant if he/she has access to patient names, your attorney if he/she has access to patient names, your janitorial staff who has access to your offices, your computer suppliers, and any consultant who sees any of your patient specific information. Anyone who has access to patient specific information must have a signed business associate contract between your practice and their entity. Otherwise you will be violating HIPAA. An example of violating HIPPA in this way could be that you release your patient information to your accountant and your accountant's computer gets hacked. Now this financial information about a patient, address, social security number, etc. is out in the world. If you do not have a business associate contract in place to protect your patient's protected health information, you are on the hook, not the one was hacked or the information was stolen from.

It is very important that you have the marketing receipt and release, acknowledgment and receipt of your privacy practices, and your business associate contract in place in your practice and updated as need be.

Security

In my reviews with clients of their practice operations, I have found that most audiologists do not have a security policy.  HIPAA requires that practices have a policy of how they will store, manage, and destroy protected health information.  The information does not have to be locked up, but there should be restricted access to it.  Who has access?  What happens in your practice if there is a breach of that access such as a stolen computer or hard drive crash?  Is this information backed up?  Where is it backed up and by whom?  Where is this information stored?  For example, if you have Sycle.net as your practice management provider, you would need a business associate contract with them because they remotely store your patient’s PHI.  You need a security policy to address this.   Where is the PHI stored?  How is it backed up?  Who has access?  Answers could include your office staff and list specific names and the janitorial staff.  All of this should be documented and it would need to be contained in the security policy.  What happens if the office gets hit by lightning?  What happens if there is a catastrophe like a flood, hurricane, or tornado?  HIPAA requires the charts are kept for 6 years.  Many third-parties and states require more time.  What happens when you have met the medical retention policies?  How do you dispose of charts?  They cannot be thrown in the trash.  Are you burning them?  Are you sending them to a document destruction service?  Who is that destruction service?  Do you have a business associate contract with them?  All of this information needs to be in writing managed by a security officer who is responsible for the maintenance, access, back-up, storage and destruction of your medical records. 

National Provider Identifier

Everyone should have a National Provider Identifier (NPI).  Dispensers can have an NPI.  If you have a dispenser who works for you, you do not bill the hearing aid that the dispenser fit under yourself.  You need to bill it under the NPI of the rendering provider.  You need an NPI for both individual providers and for the facility itself.  The exception of that is a sole proprietorship.  If you are an LLC, an S corp., or a C corp., you need a NPI for that facility as well as an NPI for each individual provider who renders service in your practice.  The NPI you are assigned will be yours forever. 

National Employer Identifier

The National Employer Identifier is a number you should obtain from the federal government when you open a business.  Sole proprietors again are an exception to that because they work under their own social security number.  However they often get EIN or tax ID numbers as well.  The NEI is also a HIPAA requirement. 

HITECH

Another HIPAA requirement that came out recently is HITECH which is about breach notification.  For example, your office is broken in to and charts were stolen.  What is your process of notifying the affected parties?  How do you find out which parties were affected?  Do you have records of that?  You need to have a policy in place about notifying affected entities of breach.  Again this should be a created document. 

HIPAA 5010

HIPAA 5010 was created for getting the electronic record set-up to take in ICD-10 and to take in some of these changes in coding that we are seeing moving forward.  If you are not HIPAA 5010 compliant, this means you would have received denial in claims because this policy went into effect in January. 

Future HIPAA Change

If you are an audiologist who is still using paper claims, I believe that in the next 5 years all paper claims will be banned.  It is very expensive and inefficient for both you and the payer to use paper claims.  They will probably only allow paper claims that require documentation.  Otherwise if you have not purchased office management software, Medicare and some payers provide free or low cost software to bill them directly.  I strongly advise that you begin reviewing these claims systems available through your Medicare area contractors or through payers directly.  Right now, if you are under 10 employees you are exempt.  I do not believe that exemption will last for the long term. 

HIPAA Training

As we talk about HIPAA it is important to realize that your staff should be trained in all of these issues.  You should have a HIPAA manual.  If you do not have these HIPAA documents, you can hire a consultant to create those for you or you can search the Internet and find information on HIPAA manual, HIPAA compliance materials, and find numerous vendors who can help supply you with these types of documents.  The training of your staff should also be documented.  You may consider having a confidentiality agreement that indicates to your employees that they are never going to take patient records home, will not take proprietary information as well as document their HIPAA training.   This training should include training on privacy, marketing, security and breach notification.  Again it is important to have documented policies on each of these and documented training on each of these on at least an annual basis.  Compliance is real business.  It is not just about the government trying to control you, but the government trying to protect patients, their rights and information from unscrupulous people. 

Key Points to Remember

1.  Read your state licensure law for Audiology and/or hearing aid dispensing.  Even if you are not licensed under the dispenser act, you are obligated to its terms.  Read the guidance that is readily available on the OIG website on compliance at https://oig.hhs.gov/. You will see compliance documents that discuss Anti-Kickback, False Claims, Stark, and Self-Referral.  You need to read the ethical practice guidelines.  If you are ASHA certified, you should read the ASHA Code of Ethics because you are held to these.  ASHA has no qualms about enforcing them.  You need to read the ethical practice guidelines for financial incentives for industry partners that AAA has done.  It can be enlightening on how these relationships can be legally problematic as well as ethically problematic.  You should read the FDA guidelines.  For those of you who see Medicare beneficiaries and are Medicare enrolled, you need to read the Update to Audiology Policies and the Revision and Re-Issuance of Audiology Policies.  You should go to the HIPAA website and read all the HIPAA material, especially if you do not have some of policies I went over in today’s presentation.  Knowledge is power and you need to know and do the right thing.  Doing the right thing is good patient care.  Read your third-party contracts as many of them address conflicts of interest, ethical responsibility, and quid pro quo.  This can be mentioned in third-party agreements with third-party payers or private payers.  This is not unique to the government.  If you are a Medicaid provider, read your Medicaid guidance.  Medicaid can have very specific ethical guidance about how you treat the indigent, how you treat Medicaid beneficiaries, and how you cannot discriminate against them. These are ethical concerns.  Someone told me they wanted to restrict the number of Medicaid patients they have.  We went to the Medicaid guidance for that state and it said this was unethical and a violation of the Medicaid guidance.  We would have never known this if we had not read it.  If you have signed an agreement, you need to read it.  If you have signed a business development fund contract, a payer contract, a lease arrangement, or an arrangement with an ordering entity and you have never had it legally vetted, you need to have this done.  You should also read the information your national association sends to you.  As someone who does this work at the national level, and my amazing colleagues at ASHA, AAA, and Educational Audiology Association, and all the people who do work on your behalf, they have guidance that they have created for you as a member.  The information is pertinent and as timely as it can be.  All this information is listed on your national association sites.  Changes to Medicare rules or coding will be listed on their website and sent in a “blast” email.  This is how you get updates on changes.  If you get mail from Medicare or a third-party payer, you should open and read it.  Open everything you get from the entities with which you contract with. 

2.  You cannot fix what you did yesterday.  Don’t lose sleep or stress over things that are done.  You can change how you move forward tomorrow.  You can right the ship.  You can renegotiate agreements.  You can change your office policies, procedures, and practices.  You can do things differently.  Most importantly you can change, but you have to do it. 

3.  If you have a colleague, an employer, or an entity with which you do business, and you are uncomfortable in the arrangement you have with them or what they want you to sign, I encourage you to seek guidance or council from another colleague or an attorney.  You can always file a complaint.  There is a whistleblower provision at the Office of Inspector General.  If you want to report fraud, you can report fraud to Medicaid, to Medicare, through OIG, and to your state licensure board.  As someone who sits on a state licensure board, we are there to investigate complaints.  You need to make sure your complaint is factual and that you have documentation that your claim is not venting.  You have to be able to substantiate what you are accusing.  If you have this information and you feel that patients are being harmed, you can always file a complaint with numerous entities such as AAA Ethical Practices or ASHA Ethical Practices board. 

4.  If in doubt, or your gut tells you that what you are doing may not be a good idea, ethical, legal, or right by the patient or profession, I recommend you consult an attorney who specializes in health care or contract law.  Attorneys can cost anywhere from $100 to $500 an hour.  It is worth it.  You would spend far more on council if you make the wrong interpretation on your own or get caught violating these laws.  I see this as preventative care of your practice and your business.  Council can guide you through your arrangements.  Maybe your arrangement is perfectly legal, you will rest better knowing this.  I do not make judgments on anything.  At face value there are many arrangements that exist in this profession that you might see and think you would never do that or it is not legal.  I am not a lawyer and I do not make those judgments.  Instead I want people to seek expert judgment and the right answer.  If an attorney in your state who understands your state laws, requirements, and legal obligations tells you that your agreement is fine, I think that is great.  I support that arrangement.  However many of us sign documents and never ask questions or have them legally vetted. 

I have numerous links available for you at the end of this presentation.  Some of these links I have added earlier in the presentation and some are additional that can help answer some ethical and legal questions you may pose in your professional practice. 

Thank you for attending this presentation and please feel free to contact me if you have questions or concerns that arise. 

Resources

• Codes of Ethics
  • AAA: https://www.audiology.org/resources/documentlibrary/Pages/codeofethics.aspx
  • ASHA: https://www.asha.org/docs/html/ET2010-00309.html

• Compliance from AAA
  • https://www.cms.gov/PhysicianFeeSched/50_Audiology.asp
     
• Audiology Policies
  • https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/Audiology.html
     
• FDA
  • https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?FR=801.421
     
• False Claims
  • https://www.cms.gov/smdl/downloads/SMD032207Att2.pdf
     
• Anti-Kickback
  • https://www.hhs.gov/ocr/privacy/hipaa/understanding/coveredentities/index.html
  • https://oig.hhs.gov/compliance/physician-education/roadmap_web_version.pdf
     
• HIPAA
  • https://www.hhs.gov/ocr/privacy/hipaa/understanding/coveredentities/index.html
  • https://www.hhs.gov/ocr/privacy/hipaa/understanding/coveredentities/marketing.html
     
• AAA and ADA Ethical Practice Guidelines on Financial Incentives from Hearing Instrument Manufacturers (2003)
  • https://www.audiology.org/resources/documentlibrary/Documents/financialincentives.pdf
     
• AAA Ethical Practice Guidelines on Financial Incentives from Industry
  • https://www.audiology.org/Pages/default.aspx